Comment: This document is troubling for several reasons, not the least of which is the apparent breach of confidentiality. Supporters of Dr. Wakefield and colleagues assert the document demonstrates a conflict of interest on the part of reporter Brian Deer, informant in the above document, and that by extension, the GMC proceeding against Dr. Wakefield and colleagues is somehow flawed or unjust. In our opinion this line of reasoning is based on several misunderstandings. First and foremost we believe journalists who report information likely to be of interest to regulator have an obligation to report these findings because, as a rule, regulatory authorities cannot evaluate a situation unless they receive a report. Generally speaking this arises from legal limits on the investigational authority of regulatory bodies. For example, many regulatory authorities can not open an investigation (solely) based on a news report. In context such limits are reasonable because, taken to extremes, it would be possible for board or council members to actively search for and report situations apparently suitable for investigation, and so prejudice themselves as objective judges to the potential or actual detriment of regulated parties.

In the U.S. there is a relatively rich tradition of regulatory action following news reports of objectionable circumstances in research, and it's quite likely the case consumers were spared from death or serious injury by the work of diligent journalists.

One common misunderstanding, and perhaps operating here, is the notion that only patients may legitimately complain to medical licensing authorities but this is simply incorrect. A good example of why this is so is the case where a patient dies. If there was suspicion that the patient's death was the result of substandard care (etc.), such a case would be of interest to the licensing authority and it should be self-evident the decedent could not report it. In point of fact, in our experience with U.S. medical and osteopathic licensing boards, complaints about physicians come not just from patients and their families but also from hospitals, health care workers, (rarely) federal agencies, and insurance companies. In some states licensing boards review malpractice cases and at the board's discretion may recommend investigation. In the document at issue the GMC indicated it received complaints from several sources in addition to Mr. Deer.

Another issue appears to be some lack of understanding of the way in which regulatory authorities handle complaints. As we stress on our web page on complaints about research consumers should not be afraid of getting somebody into trouble by complaining or asking questions. Properly speaking, complaints are allegations. In this case, the GMC, like most regulatory authorities, evaluated an allegation and determined an investigation was warranted. Based upon the results of its investigation, a decision was made to charge Dr. Wakefield and colleagues. We should also keep in mind the hearing panel has yet to render a decision, and accordingly Dr. Wakefield and his colleagues are innocent unless and until proven otherwise.

Our most serious concern about the release of this document is that it may tend to dissuade research subjects from complaining to the regulator for fear of breach of confidentiality or retribution. Consumers should keep in mind that an allegation of noncompliance is not the same thing as a finding or judgment by the regulator, and that an allegation is but the first step in a long process. More to the point, in our experience, such a breach of confidentiality is virtually unheard of and hopefully will remain this way. while supporters of Dr. Wakefield surely prefer that charges had not been filed by the GMC, in our opinion it's not correct that Mr. Deer was solely and entirely responsible for the charges, and we believe that all reporters have an obligation to report concerns arising from their work to the appropriate regulator where warranted by their professional judgment. The bottom line is that research is everyone's business, and all the more so in the absence of effective regulation to protect research subjects.

UK Research Policy: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH): http://www.ich.org/LOB/media/MEDIA482.pdf

Serial No. 107-121. The Status of Research into Vaccine Safety and Autism. Committee on Government Reform and Oversight. House of Representatives. 107th Congress, Second Session. June 19, 2002. Available from http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_house_hearings&docid=f:82358.pdf [File size: 16.2M]
Witnesses: AJ Wakefield, Jeffrey Bradstreet, Vera Stejskal, Arthur Krigsman, Frank DeStephano, Robert Chen, Roger Bernier, Stephen Foote, William Egan.

Serial No. 107-153. Vaccines and the Autism Epidemic: Reviewing the Federal Government's Track Record and Charting a Course for the Future. Committee on Government Reform and Oversight. House of Representatives. 107th Congress, Second Session. December 10, 2002. Available from http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_house_hearings&docid=f:84605.pdf [File size: 15M]
Witnesses: Mark Geier, Walter Spitzer, David Baskin, Karen Midthun, Stephen Foote, Christopher Portier.

In RE: Claims for Vaccine Injuries etc. Autism Master File U.S. Federal Court of Claims Office Special Masters. Respondent's Response to Petitioners' Second Motion to Compel and Motion for Issuance of Third-Party Subpoenas. 2007-01-19: [affidavit of interest at p. 47 and ff.] http://www.circare.org/autism/20070119_autismwithexhibits.pdf

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